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Topical emollient for preventing infection in preterm infants

  • Review
  • Intervention

Authors


Abstract

Background

Breakdown of the developmentally immature epidermal barrier may permit entry for micro-organisms leading to invasive infection in preterm infants. Topical emollients may improve skin integrity and barrier function and thereby prevent invasive infection, a major cause of mortality and morbidity in preterm infants.

Objectives

To assess the effect of topical application of emollients (ointments, creams, or oils) on the incidence of invasive infection, other morbidity, and mortality in preterm infants.

Search methods

We used the standard search strategy of the Cochrane Neonatal Review group to search the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 7), MEDLINE via PubMed (1966 to August 2015), EMBASE (1980 to August 2015), and CINAHL (1982 to August 2015). We also searched clinical trials databases, conference proceedings, previous reviews and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials.

Selection criteria

Randomised or quasi-randomised controlled trials that assessed the effect of prophylactic application of topical emollient (ointments, creams, or oils) on the incidence of invasive infection, mortality, other morbidity, and growth and development in preterm infants.

Data collection and analysis

Two review authors assessed trial eligibility and risk of bias and undertook data extraction independently. We analysed the treatment effects in the individual trials and reported the risk ratio and risk difference for dichotomous data and mean difference for continuous data, with respective 95% confidence intervals. We used a fixed-effect model in meta-analyses and explored the potential causes of heterogeneity in subgroup analyses.

Main results

We identified 18 eligible primary publications (21 trial reports). A total of 3089 infants participated in the trials. The risk of bias varied with lack of clarity on methods to conceal allocation in half of the trials and lack of blinding of caregivers or investigators in all of the trials being the main potential sources of bias.

Eight trials (2086 infants) examined the effect of topical ointments or creams. Most participants were very preterm infants cared for in health-care facilities in high-income countries. Meta-analyses did not show evidence of a difference in the incidence of invasive infection (typical risk ratio (RR) 1.13, 95% confidence interval (CI) 0.97 to 1.31; low quality evidence) or mortality (typical RR 0.87, 95% CI 0.75 to 1.03; low quality evidence).

Eleven trials (1184 infants) assessed the effect of plant or vegetable oils. Nine of these trials were undertaken in low- or middle-income countries and all were based in health-care facilities rather than home or community settings. Meta-analyses did not show evidence of a difference in the incidence of invasive infection (typical RR 0.71, 95% CI 0.51 to 1.01; low quality evidence) or mortality (typical RR 0.94, 95% CI 0.81 to 1.08; moderate quality evidence). Infants massaged with vegetable oil had a higher rate of weight gain (about 2.55 g/kg/day; 95% CI 1.76 to 3.34), linear growth (about 1.22 mm/week; 95% CI 1.01 to 1.44), and head growth (about 0.45 mm/week; 95% CI 0.19 to 0.70). These meta-analyses contained substantial heterogeneity.

Authors' conclusions

The available data do not provide evidence that the use of emollient therapy prevents invasive infection or death in preterm infants in high-, middle- or low-income settings. Some evidence of an effect of topical vegetable oils on neonatal growth exists but this should be interpreted with caution because lack of blinding may have introduced caregiver or assessment biases. Since these interventions are low cost, readily accessible, and generally acceptable, further randomised controlled trials, particularly in both community- and health care facility-based settings in low-income countries, may be justified.

摘要

背景

早產兒使用局部藥膏以避免感染

院內感染對於早產兒來說是一個頻繁和嚴重的併發症。由於相對於比較成熟的新生兒,其免疫功能較差,且較需要侵入性的支持治療,因此,更增加了感染的易感受性。被破壞屏障功能的皮膚可能是一種額外的風險會造成院內敗血症。

目標

評估預防性使用局部藥膏來預防早產兒發生院內敗血症率及其他併發症。

搜尋策略

搜查從2003年6月開始的Cochrane中央登記處的對照試驗(CENTRAL, The Cochrane Library, Issue 2, 2003),Ovid DC MEDLINE ,前人的review,包括交叉引用,摘要,會議和專題討論會程序,專家訊息和英文雜誌搜索。

選擇標準

本試驗採取隨機對照試驗,比較早產兒中預防性地例行使用局部軟膏理或視需要局部治療的效果。

資料收集與分析

審查者收錄集了臨床試驗報告中的結果,包括感染[包括任何細菌感染,已知病原體的細菌感染,凝固?陰性葡萄球菌感染,真菌感染,任何院內感染(細菌或真菌) ,開放性動脈導管,在28天時仍需氧氣,慢性肺病疾病和死亡率。數據分析是根據科克倫新生兒審查小組所訂定的標準完成。

主要結論

本審查中包含了4個隨機對照試驗。所有4個研究報告認為嬰幼兒預防性使用局部軟膏改善皮膚狀況(此處沒有報告結果)。所有研究報告了任何院內感染,真菌感染和凝固?陰性葡萄球菌感染的發病率。使用預防性局部軟膏的嬰幼兒可能面臨更大的風險感染凝固?陰性葡萄球菌(typical relative risk: 1.31,95 % CI為1.02, 1.70; typical risk difference: 0.04, 95 % CI為0.00, 0.08); 和任何院內感染(typical relative risk 1.20, 95 % CI為1.00, 1.43; typical risk difference 0.05,95 % CI為0.00, 0.09)。在使用預防性局部軟膏的嬰兒中發現,任何細菌感染的風險有增加的趨勢(typical relative risk: 1.19,95 % CI為0.97, 1.46; typical risk difference: 0.04,95 % CI為−0.01,0.08)。而已知病原體的細菌感染、真菌感染,或其他相關的早產併發症並無顯著差異。

作者結論

預防性使用局部軟膏增加了凝固脢陰性葡萄球菌感染與任何院內感染的危險性。而預防性使的嬰兒對於任何細菌感染也有危險性增加的趨勢。外用軟膏不應常規使用於早產兒。

翻譯人

本摘要由高雄醫學大學附設醫院吳佩玲翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

等待摘要

Plain language summary

Topical emollient for preventing infection in preterm infants

Review question: Does the topical application of emollients reduce the incidence of invasive infection in preterm infants?

Background: Preterm infants (born before 37 weeks' gestation) are susceptible to bloodstream and other serious infections partly because their immature skin is not a fully effective barrier to micro-organisms. Applying emollient (ointment, cream, or oil) may protect against skin breakdown and thereby prevent micro-organisms from spreading into the bloodstream and causing serious infection.

Study characteristics: Our search (August 2015) identified 21 eligible trial reports (in 18 primary publications). In total, 3089 infants participated. Eight trials (2086 infants) examined the effect of topical ointments or creams. Most participants were very preterm infants cared for in health-care facilities in high-income countries. Eleven trials (1184 infants) assessed the effect of sunflower, sunflower seed, and other vegetable oils. Nine of these trials were undertaken in low- or middle-income countries and all were based in health-care facilities rather than home or community settings.

Results: Analyses of these trial data provided low quality evidence and did not show that emollients prevent infection or death in preterm infants.

Conclusions: These analyses do not provide evidence that the use of emollient therapy prevents invasive infection or death in preterm infants in high-, middle- or low-income countries. Since these interventions are low cost, readily accessible and generally acceptable, further randomised controlled trials, particularly in both community- and health care facility-based settings in low-income countries, may be justified.